A Study to Compare the Efficacy and Safety of Idecabtagene Vicleucel With Lenalidomide Maintenance Therapy Versus Lenalidomide Maintenance Therapy Alone in Adult Participants With Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Autologous Stem Cell Transplantation

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

618

Participants

Timeline

Start Date

October 16, 2023

Primary Completion Date

August 11, 2025

Study Completion Date

August 11, 2025

Conditions
Multiple Myeloma
Interventions
BIOLOGICAL

idecabtagene vicleucel

Specified dose on specified days

DRUG

Lenalidomide

Specified dose on specified days

DRUG

Fludarabine

Specified dose on specified days

DRUG

Cyclophosphamide

Specified dose on specified days

Trial Locations (101)

1070

Local Institution - 0083, Anderlecht

1090

Local Institution - 0090, Vienna

Local Institution - 0084, Brussels

1200

Local Institution - 0144, Brussels

2050

Local Institution - 0007, Camperdown

3000

Local Institution - 0004, Melbourne

3004

Local Institution - 0006, Melbourne

3065

Local Institution - 0008, Melbourne

4029

Local Institution - 0005, Brisbane

5000

Local Institution - 0070, Odense

5020

Local Institution - 0089, Salzburg

6150

Local Institution - 0011, Murdoch

10032

Columbia University Irving Medical Center, New York

12462

Local Institution - 0062, Chaïdári

13273

Institut Paoli-Calmettes, Marseille

19104

Local Institution - 0132, Philadelphia

20089

Local Institution - 0064, Rozzano

20246

Local Institution - 0076, Hamburg

26504

Local Institution - 0063, Pátrai

28041

Local Institution - 0021, Madrid

28204

Novant Health Cancer Institute - Elizabeth, Charlotte

30322

Local Institution - 0121, Atlanta

30342

Local Institution - 0104, Atlanta

31008

Local Institution - 0012, Pamplona

31096

Local Institution - 0056, Haifa

31100

Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE, Toulouse

32804

AdventHealth Orlando, Orlando

33600

Local Institution - 0047, Pessac

37007

Local Institution - 0013, Salamanca

40138

Local Institution - 0065, Bologna

43210

The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center, Columbus

44000

Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu, Nantes

45122

Local Institution - 0115, Essen

46026

Hospital Universitari i Politecnic La Fe, Valencia

48075

Ascension Providence Hospital, Southfield

50937

Local Institution - 0073, Cologne

55455

M Health Fairview Clinics and Surgery Center, Minneapolis

58128

Chonnam National University Hwasun Hospital, Hwasun

59000

Hopital Claude Huriez - CHU de Lille, Lille

63108

Washington University School of Medicine, St Louis

63110

Washington University School of Medicine, St Louis

69120

Local Institution - 0072, Heidelberg

69310

Local Institution - 0046, Pierre-Bénite

75010

Local Institution - 0082, Paris

75571

Local Institution - 0031, Paris

77030

Local Institution - 0109, Houston

University of Texas MD Anderson Cancer Center, Houston

78704

Local Institution - 0124, Austin

80218

Colorado Blood Cancer Institute, Denver

86021

Local Institution - 0029, Poitiers

89081

Local Institution - 0078, Ulm

90095

Local Institution - 0131, Los Angeles

90419

Local Institution - 0077, Nuremberg

92868

Local Institution - 0126, Orange

94010

Henri Mondor Hospital, Créteil

94805

Local Institution - 0028, Villejuif

95817

Local Institution - 0113, Sacramento

97080

Local Institution - 0074, Würzburg

4910021

Local Institution - 0058, Petah Tikva

5262100

Local Institution - 0057, Ramat Gan

6423906

Local Institution - 0088, Tel Aviv

8410101

Local Institution - 0055, Beersheba

9112001

Local Institution - 0059, Jerusalem

06510

Yale University School of Medicine, New Haven

02215

Local Institution - 0151, Boston

T6G 1Z2

Local Institution - 0133, Edmonton

L8V5C2

Local Institution - 0001, Hamilton

H1T 2M4

Local Institution - 0134, Montreal

04103

Local Institution - 0087, Leipzig

01307

Local Institution - 0079, Dresden

106 76

Local Institution - 0061, Athens

570 10

Local Institution - 0060, Thessaloniki

00161

Local Institution - 0066, Roma

467-8602

Nagoya City University Hospital, Nagoya

060-8648

Hokkaido University Hospital, Sapporo

663-8501

Hyogo Medical University Hospital, Nishinomiya

920-8641

Kanazawa University Hospital, Kanazawa

259-1193

Local Institution - 0085, Isehara

150-8935

Japanese Red Cross Medical Center, Shibuya-ku

260-8677

Chiba University Hospital, Chiba

812-8582

Kyushu University Hospital, Fukuoka

700-8558

Okayama University Hospital, Okayama

329-0498

Local Institution - 0071, Shimotsuke

0372

Local Institution - 0069, Oslo

20-090

Local Institution - 0027, Lublin

02-097

Local Institution - 0095, Warsaw

02-776

Local Institution - 0023, Warsaw

44-101

Local Institution - 0022, Gliwice

80-952

Local Institution - 0026, Gdansk

60-569

Local Institution - 0024, Poznan

022328

Local Institution - 0091, Bucharest

03080

Seoul National University Hospital, Seoul

06351

Local Institution - 0038, Seoul

06591

Local Institution - 0043, Seoul

05505

Asan Medical Center, Seoul

08916

Local Institution - 0020, Badalona

08908

Local Institution - 0017, L'Hospitalet Del Llobregat

08036

Hospital Clínic de Barcelona, Barcelona

B15 2TH

Local Institution - 0093, Birmingham

SE5 9RS

Local Institution - 0080, London

W12 0HS

Local Institution - 0094, London

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

collaborator

2seventy bio

INDUSTRY

lead

Celgene

INDUSTRY